🧰 Job Title:
Manager, Regulatory Affairs (Power Tools)
Company: Johnson & Johnson – MedTech Orthopaedics, Inc.
🔗 Learn More About J&J
📍 Location (Hybrid Work):
Preferred: Palm Beach Gardens, FL, USA
Also considered: Oberdorf or Zuchwil, Switzerland
Hybrid schedule: 3 days/week in-office; remote not available
📅 Job Details:
Function: Regulatory Affairs
Sub-function: Regulatory Affairs
Category: Manager, Regulatory Affairs (PL7)
Work Pattern: Hybrid
Requisition Numbers:
USA: R-021721
Switzerland: R-023294
Date Posted: September 3, 2025
Anticipated Close Date: September 17, 2025 (subject to extension)
🧭 Position Overview:
The Manager, Regulatory Affairs will lead and coordinate global regulatory activities related to new and modified Power Tools products within the Orthopaedics group. This individual will play a critical role in driving submission strategies, ensuring compliance, and maintaining market access in both the U.S. and European regions.
🛠️ Key Responsibilities:
Lead preparation and coordination of regulatory submissions (e.g., 510(k), PMA, Technical Files, Design Dossiers).
Interact with regulatory authorities to expedite product approvals and resolve issues.
Guide project teams on regulatory strategy and compliance.
Ensure all submissions and documentation align with regulatory requirements and internal SOPs.
Support product development teams in preparing outlines, reports, and regulatory documentation.
Ensure timely and effective support for product launches and post-market regulatory needs.
Monitor global regulatory trends and requirements to maintain regulatory compliance.
Collaborate with cross-functional stakeholders including engineering, quality, marketing, and legal teams.
Potentially supervise or mentor junior regulatory team members; assign tasks and provide development support.
Ensure compliance with J&J policies and industry regulations across all activities.
📚 Required Qualifications:
🎓 Education:
Minimum: Bachelor’s degree in science, engineering, business, or legal discipline
Preferred: Advanced degree (MS, PhD, or related)
🧠 Experience:
U.S. & European regulatory experience in the medical device industry is required
8+ years of regulatory affairs experience (6+ with Master’s, 5+ with PhD)
Experience preparing and submitting:
U.S. regulatory submissions: 510(k), PMA
European filings: Technical Files, Design Dossiers
Demonstrated success in:
Developing and implementing global regulatory strategies
Supporting cross-functional product development teams
FTE leadership or people management experience is a plus
✅ Key Competencies:
Strong knowledge of global medical device regulations and standards
Excellent written and verbal communication skills
Able to analyze scientific and technical literature, financial and legal documents
Comfortable presenting complex information to senior leadership
Strong organizational and project management skills
Capable of handling inquiries from regulatory agencies, customers, and business partners
💬 Workplace Culture & Accessibility:
Johnson & Johnson is committed to:
A diverse and inclusive workplace
Providing equal opportunity to all qualified applicants
Ensuring an accessible hiring process for individuals with disabilities
📧 For accommodation requests, contact:
ra-employeehealthsup@its.jnj.com
Or use AskGS to be connected with the appropriate support resource.
⚖️ Equal Opportunity Statement:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration regardless of:
Race, color, religion
Sex, sexual orientation, gender identity
Age, national origin
Disability, protected veteran status, or any legally protected status
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